Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV

NCT05078957 | Recruiting

• 1 other identifier: 21-33
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people. In this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis. The objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Variation of the Shannon index between 0 and 5 years in different groups of PLWH

  Five years

Secondary Outcomes (3)

• Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail)

  Three years

• Assaying inflammation markers(CRP, IL-6, sCD14, sCD163, TNFa, IP10, I-FABP, LBP, D-dimers, K/T ratio) annually and for 5 years in different groups of PLWH

  Five years

• Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWH

  Five years

Study Arms (3)

Frail PLWH

Other: Stool sampling; Other: Frailty phenotype; Other: Blood plasma collection

Pre frail PLWH

Other: Stool sampling; Other: Frailty phenotype; Other: Blood plasma collection

No frail PLWH

Other: Stool sampling; Other: Frailty phenotype; Other: Blood plasma collection

Interventions

Stool sampling OTHER

Stool samples will be collected from participants at baseline and annually during 5 years

Frail PLWH; No frail PLWH; Pre frail PLWH

Frailty phenotype OTHER

According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.

Frail PLWH; No frail PLWH; Pre frail PLWH

Blood plasma collection OTHER

Blood plasma collection to measure persistent inflammation and immune activation

Frail PLWH; No frail PLWH; Pre frail PLWH

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People Living with HIV (PLWH)

You may qualify if:

• Subject with ongoing HIV follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / mL for at least 5 years (tolerance of blips \< 200 copies / mL during this period)
• Aged ≥ 55 at baseline
• CD4 + T cell nadir\> 200 / mm3
• Giving free and informed written consent
• Being affiliated with or benefiting from a social security scheme.

You may not qualify if:

• Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
• Subject not followed regularly in the participating center,
• Subject only coming for full hospitalization
• Subject in the primary infection phase of less than 1 year

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, 13003, France

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Myriam BENNANI

CONTACT

0413428351; m.bennani@hopital-europeen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 15, 2021
• Study Start: December 5, 2023
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

FR (1)